Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

NCT02110784 | Terminated Phase 2

• 2 other identifiers: ST3073-ST3074-DM13-0012013-003763-56
• Study Type: interventional
• Target: 27
• Locations: 7 countries
• Sites: 13

Brief Summary

The aim of the present study is to investigate the efficacy, safety and tolerability of a therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P. vivax in endemic countries.

Conditions

Malaria, Vivax

Keywords

Artemisinin based Combination Therapies; eurartesim; Dihydroartemisinin/Piperaquine

Outcome Measures

Primary Outcomes (1)

• Uncorrected adequate clinical and parasitological response (ACPR)

  The uncorrected ACPR will be considered met for all those patients that are not presenting parasitaemia and fever at day 21 follow-up visit.

  21 days after the start of treatment

Secondary Outcomes (4)

• Proportion of aparasitaemic patients

  at day 1, 2, 3, 7, 21, 42

• Proportion of afebrile patients

  at day 1, 2, 3, 7, 21, 42

• uncorrected ACPR

  at day 42

• Number of Patients with Serious and Non-Serious Adverse Events

  up to 42 days from starting of treatment

Study Arms (1)

Eurartesim tablets

EXPERIMENTAL

Eurartesim 320 mg piperaquine / 40 mg dihydroartemisinin film coated tablets. one or more tablets according to the body weight, once a day dor three consecutive days.

Drug: Eurartesim tablets

Interventions

Eurartesim tablets DRUG

dosage bands: 24 to \<36 kg body weight: 2 tablets a day for three consecutive days 36 to \<75 kg body weight: 3 tablets a day for three consecutive days 75 to 100 kg body weight: 4 tablets a day for three consecutive days

Also known as: dihydroartemisinin/Piperaquine

Eurartesim tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have read the Information for the Patient and signed the Informed Consent Form;
• Aged ≥18 years and able to swallow oral medication;
• Body weight comprised between 24 kg and 100 kg (included) for males and females;
• Uncomplicated malaria with microscopically confirmed monoinfection by Plasmodium vivax or mixed infection (i.e. infection with P. vivax and other Plasmodium species);
• Willingness to comply with the study protocol and the study visit schedule.

You may not qualify if:

• Participation in any investigational drug study during the previous 30 days;
• Antimalarial treatment with chloroquine and quinine within the previous 6 weeks, with piperaquine-based compounds or mefloquine or lumefantrine within the previous 3 months and with halofantrine within the previous 30 days prior to screening;
• P. vivax/Plasmodium species asexual stage parasitaemia ≥ 5% Red Blood Cells (in cases of mixed infection);
• Clinical and/or laboratory features of severe malaria according to WHO criteria (WHO 2010);
• ECG abnormality that requires urgent management (i.e. clinically significant arrhythmias, Atrio-Ventricular block II and III degree etc.);
• Family history of sudden death, or known congenital prolongation of the QT interval
• Lengthening of QT interval on ECG: corrected QT interval (Fridericia's correction) ≥450 ms for males and ≥470 ms for females;
• Concomitant administration of any treatment which can induce a lengthening of QT interval (i.e. antihistamines, macrolides, etc.) and of any antimalarial drugs (for the full list of prohibited drugs refer to section 8.3);
• Any contraindication to blood sampling (i.e. important haemorrhagic diathesis);;
• Presence of intercurrent illness or any condition (i.e. severe vomiting and dehydration) which in the judgement of the Investigator would place the patient at undue risk or interfere with the study results;
• Hypoglycaemia (blood glucose levels \< 2.2 mmol/L or \< 40 mg/dL);
• Splenectomy;
• Pregnant or lactating women. During the study period (Day 0- Day 42), fertile women who are sexually active must use an adequate birth control method. They should utilize oral or patch contraceptives, contraceptive implant or depot injection or an intrauterine device from at least one month before screening and during the whole study period. In all the other cases they have to agree to remain inactive or use condoms with a spermicidal agent during the study period;
• Presence of jaundice;
• Known renal impairment (serum creatinine \> 2X the upper limit of the hospital laboratory reference range);

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (13)

Hôpital St André-CHU, Médecine interne et Maladies tropicales

Bordeaux, France

Location

Medizinische Klinik mit Schwerpunkt Infektiologie, Charite/Campus Virchow-Klinikum

Berlin, Germany

Location

Department of Infectious Diseases & Tropical Medicine, University of Munich

Munich, Germany

Location

15. The Center for Geographic Medicine and Tropical Diseases, Department of Medicine C - The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Clinica di Malattie Infettive e Tropicali, Universitá di Brescia

Brescia, Italy

Location

Azienda ospedaliera Luigi Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliera Arcispedale S. Maria Nuova IRCCS - Dip. Medicina Interna e Spec. Mediche

Reggio Emilia, 42123, Italy

Location

Centro di Malattie Tropicali - INMI Spallanzani

Roma, Italy

Location

Dep. Infectious Disease, Section Travel Medicine, Leiden University Medical Centre

Leiden, Netherlands

Location

CRESIB-Hospital Clinic, Barcelona

Barcelona, Spain

Location

Hospital Vall d'Hebron, Barcelona

Barcelona, Spain

Location

Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute

Basel, Switzerland

Location

Bern University Hospital

Bern, Switzerland

Location

Related Publications (3)

• Hasugian AR, Purba HL, Kenangalem E, Wuwung RM, Ebsworth EP, Maristela R, Penttinen PM, Laihad F, Anstey NM, Tjitra E, Price RN. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and posttreatment prophylaxis against multidrug-resistant Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis. 2007 Apr 15;44(8):1067-74. doi: 10.1086/512677. Epub 2007 Mar 5.

  PMID: 17366451 BACKGROUND

• Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.

  PMID: 17336652 BACKGROUND

• Sinclair D, Gogtay N, Brand F, Olliaro P. Artemisinin-based combination therapy for treating uncomplicated Plasmodium vivax malaria. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD008492. doi: 10.1002/14651858.CD008492.pub2.

  PMID: 21735431 BACKGROUND

MeSH Terms

Conditions

Malaria, Vivax

Interventions

artenimol; piperaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Christoph Hatz, Prof Dr Med

  Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute, Basel - Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: June 18, 2014
• Primary Completion: November 23, 2016
• Study Completion: April 30, 2017
• Last Updated: September 17, 2018

Record last verified: 2017-06

Locations

DE (2); ES (2); NL (1); IT (4); CH (2); FR (1); IL (1)